BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 2220262 · Received August 16, 2011

    Report

    Report Number
    1822565-2011-01890
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION PROCESS FOR THESE DEVICES WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10 -6 OR BETTER. IN ADDITION, BEFORE EACH MFG LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM STERIGENICS (STERILIZATION SUPPLIER) IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM, AND ACTUAL GAMMA DOSE IN KGY. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE PT INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBER REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, (B)(4) CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT INCISION AND DRAINAGE DUE TO RIGHT HIP INFECTION. THE ACETABULAR LINER AND HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL HEAD LPH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention TRILOGY LONGEVITY CONSTRAINED LINER,| CATALOG #00633405028, LOT # UNK